STTR Phase I: Protective T Cell Vaccine for SARS CoV-2 (COVID-19)

这一小型企业技术转让(STTR)第一阶段项目的更广泛影响/商业潜力是开发一种完全不同的下一代SARS CoV-2疫苗，以解决目前在有效性、安全性以及国内和全球疫苗分销方面的差距。高度传染性的Delta变种在全球迅速出现，突显了T细胞免疫的重要性，T细胞免疫越来越被认为是对SARS CoV-2产生有效和长期免疫的关键。一种创新的DNA疫苗，作为一种患者友好的鼻腔喷雾提供，不需要冷藏，将改善公共健康。这项小型企业技术转移(STTR)第一阶段项目通过鼻腔/肺内注射磷酸钙纳米颗粒配制的质粒来推动多价SARS CoV-2 T细胞疫苗的发展。组成SARS CoV-2 ORFeome的蛋白将被克隆到专有质粒(Aim 1)中，通过体外攻击康复供者的PBMC(Aim 2)和在hACE2小鼠体内安全/免疫原性/挑战进行筛选。第一阶段的结果将是识别在体内引起T细胞反应的新型ORF，以及针对SARS CoV-2挑战的部分保护(感染后14天存活率为50%)。该奖项反映了NSF的法定使命，并已通过使用基金会的智力优势和更广泛的影响审查标准进行评估，被认为值得支持。

The broader impact /commercial potential of this Small Business Technology Transfer (STTR) Phase I project is to develop a fundamentally different next-generation SARS CoV-2 vaccine that addresses current gaps in efficacy, safety, and national and global distribution of vaccines. The rapid global emergence of the highly infectious delta variant underscores the importance of T cell immunity, increasingly recognized as critical to eliciting effective and long-term immunity to SARS CoV-2. An innovative DNA vaccine, delivered as a patient-friendly intranasal spray that does not require refrigeration, will improve public health. This Small Business Technology Transfer (STTR) Phase I project advances a multivalent SARS CoV-2 T cell vaccine by intranasal/pulmonary administration of calcium phosphate nanoparticle-formulated plasmids. Proteins comprising the SARS CoV-2 ORFeome will be cloned in proprietary plasmids (Aim 1) screened by in vitro challenge with PBMC from recovered donors (Aim 2) and safety/immunogenicity/challenge in vivo in hACE2 mice. The outcome of Phase I will be identification novel ORFs that elicit T cell responses in vivo and that in combination partially protective (50% survival at 14 days post infection) against challenge with SARS CoV-2.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.